Intralipid 10%

INDICATIONS

INTRALIPID® 10% (10% i.v fat emulsion) IS INDICATED AS A SOURCE OF CALORIES AND ESSENTIAL FATTY
ACIDS FOR PATIENTS REQUIRING PARENTERAL NUTRITION FOR EXTENDED PERIODS OF TIME
(USUALLY FOR MORE THAN 5 DAYS) AND AS A SOURCE OF ESSENTIAL FATTY ACIDS FOR
PREVENTION OF EFAD.

DOSAGE AND ADMINISTRATION

ADULT PATIENTS

THE INITIAL RATE OF INFUSION IN ADULTS SHOULD BE 1 ML/MINUTE FOR THE FIRST
15 TO 30 MINUTES OF INFUSION. IF NO UNTOWARD REACTIONS OCCUR (SEE ADVERSE
REACTIONS SECTION), THE INFUSION RATE CAN BE INCREASED TO 2 ML/MINUTE.
NOT MORE THAN 500 ML OF INTRALIPID® 10% (10% i.v fat emulsion) (A 10% INTRAVENOUS FAT EMULSION)
SHOULD BE INFUSED INTO ADULTS ON THE FIRST DAY OF THERAPY. IF THE PATIENT HAS
NO UNTOWARD REACTIONS, THE DOSE CAN BE INCREASED ON THE FOLLOWING DAY. THE DAILY
DOSAGE SHOULD NOT EXCEED 2.5 G OF FAT/KG OF BODY WEIGHT (25 ML OF INTRALIPID®
10% PER KG). INTRALIPID® 10% (10% i.v fat emulsion) SHOULD MAKE UP NO MORE THAN 60% OF THE TOTAL
CALORIC INPUT TO THE PATIENT. CARBOHYDRATE AND A SOURCE OF AMINO ACIDS SHOULD
COMPRISE THE REMAINING CALORIC INPUT.

PEDIATRIC PATIENTS

THE DOSAGE FOR PREMATURE INFANTS STARTS AT 0.5 G FAT/KG BODY WEIGHT/24 HOURS
(5 ML INTRALIPID® 10% (10% i.v fat emulsion) ) AND MAY BE INCREASED IN RELATION TO THE INFANTS
ABILITY TO ELIMINATE FAT. THE MAXIMUM DOSAGE RECOMMENDED BY THE AMERICAN ACADEMY
OF PEDIATRICS IS 3 G FAT/KG/24 HOURS3. THE INITIAL RATE OF INFUSION
IN OLDER PEDIATRIC PATIENTS SHOULD BE NO MORE THAN 0.1 ML/MINUTE FOR THE FIRST
10 TO 15 MINUTES. IF NO UNTOWARD REACTIONS OCCUR, THE RATE CAN BE CHANGED TO
PERMIT INFUSION OF 1 ML OF INTRALIPID® 10% (10% i.v fat emulsion) /KG/HOUR. THE DAILY DOSAGE SHOULD
NOT EXCEED 3 G OF FAT/KG OF BODY WEIGHT3. INTRALIPID® 10% (10% i.v fat emulsion) SHOULD MAKE UP
NO MORE THAN 60% OF THE TOTAL CALORIC INPUT TO THE PATIENT. CARBOHYDRATE AND
A SOURCE OF AMINO ACIDS SHOULD COMPRISE THE REMAINING CALORIC INPUT.

ESSENTIAL FATTY ACID DEFICIENCY

WHEN INTRALIPID® 10% (A 10% I.V. FAT EMULSION) IS ADMINISTERED TO CORRECT
ESSENTIAL FATTY ACID DEFICIENCY, EIGHT TO TEN PERCENT OF THE CALORIC INPUT SHOULD
BE SUPPLIED BY INTRALIPID® 10% (10% i.v fat emulsion) IN ORDER TO PROVIDE ADEQUATE AMOUNTS OF LINOLEIC
AND LINOLENIC ACIDS. WHEN EFAD OCCURS TOGETHER WITH STRESS, THE AMOUNT OF INTRALIPID®
10% NEEDED TO CORRECT THE DEFICIENCY MAY BE INCREASED.

ADMINISTRATION

SEE MIXING GUIDELINES AND LIMITATIONS SECTION FOR INFORMATION REGARDING
MIXING THIS FAT EMULSION WITH OTHER PARENTERAL FLUIDS.

INTRALIPID® 10% (10% i.v fat emulsion) CAN BE INFUSED INTO THE SAME CENTRAL OR PERIPHERAL VEIN
AS CARBOHYDRATE/AMINO ACIDS SOLUTIONS BY MEANS OF A Y-CONNECTOR NEAR THE INFUSION
SITE. THIS ALLOWS FOR MIXING OF THE EMULSION IMMEDIATELY BEFORE ENTERING THE
VEIN OR FOR ALTERNATION OF EACH PARENTERAL FLUID. IF INFUSION PUMPS ARE USED,
FLOW RATES OF EACH PARENTERAL FLUID SHOULD BE CONTROLLED WITH A SEPARATE PUMP.
FAT EMULSION MAY ALSO BE INFUSED THROUGH A SEPARATE PERIPHERAL SITE. FILTERS
OF LESS THAN 1.2 MICRON PORE SIZE MUST NOT BE USED WITH INTRALIPID® 10% (10% i.v fat emulsion) .

DO NOT USE ANY BAG IN WHICH THERE APPEARS TO BE AN OILING OUT ON THE SURFACE
OF THE EMULSION. PARENTERAL DRUG PRODUCTS SHOULD BE INSPECTED VISUALLY FOR PARTICULATE
MATTER AND DISCOLORATION PRIOR TO ADMINISTRATION, WHENEVER SOLUTION AND CONTAINER
PERMIT.

MIXING GUIDELINES AND LIMITATIONS

INVESTIGATIONS HAVE BEEN CONDUCTED WHICH DEMONSTRATE THE COMPATIBILITY OF INTRALIPID®
10% WHEN PROPERLY MIXED WITH EITHER NOVAMINE® OR 8.5% TRAVASOL® OR 10%
TRAVASOL® AMINO ACID INJECTIONS WITHOUT ELECTROLYTES FOR USE IN TPN THERAPY.
THE FOLLOWING PROPER MIXING SEQUENCE MUST BE FOLLOWED TO MINIMIZE PH RELATED
PROBLEMS BY ENSURING THAT TYPICALLY ACIDIC DEXTROSE INJECTIONS ARE NOT MIXED
WITH LIPID EMULSIONS ALONE:

THESE ADMIXTURES SHOULD BE USED PROMPTLY WITH STORAGE UNDER REFRIGERATION (2-8°C)
NOT TO EXCEED 24 HOURS AND MUST BE COMPLETELY USED WITHIN 24 HOURS AFTER REMOVAL
FROM REFRIGERATION.

IT IS ESSENTIAL THAT THE ADMIXTURE BE PREPARED USING STRICT ASEPTIC TECHNIQUES
AS THIS NUTRIENT MIXTURE IS A GOOD GROWTH MEDIUM FOR MICROORGANISMS.

ADDITIVES OTHER THAN THOSE NAMED ABOVE MAY BE INCOMPATIBLE. COMPLETE INFORMATION
IS NOT AVAILABLE. THOSE ADDITIVES KNOWN TO BE INCOMPATIBLE SHOULD NOT BE USED.
CONSULT WITH PHARMACIST, IF AVAILABLE. IF, IN THE INFORMED JUDGMENT OF THE PHYSICIAN,
IT IS DEEMED ADVISABLE TO INTRODUCE ADDITIVES, USE ASEPTIC TECHNIQUE. MIX THOROUGHLY
WHEN ADDITIVES HAVE BEEN INTRODUCED. DO NOT STORE SOLUTIONS CONTAINING ADDITIVES
(E.G., VITAMINS AND MINERALS). ADDITIVES MUST NOT BE ADDED DIRECTLY TO INTRALIPID®
10% AND IN NO CASE SHOULD INTRALIPID® 10% (10% i.v fat emulsion) BE ADDED TO THE TPN CONTAINER
FIRST. BAGS SHOULD BE SHAKEN GENTLY AFTER EACH ADDITION TO MINIMIZE LOCALIZED
CONCENTRATION.

SUPPLEMENTAL ELECTROLYTES, TRACE METALS OR MULTIVITAMINS MAY BE REQUIRED IN
ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN.

THE PRIME DESTABILIZERS OF EMULSIONS ARE EXCESSIVE ACIDITY (LOW PH) AND INAPPROPRIATE
ELECTROLYTE CONTENT. CAREFUL CONSIDERATION SHOULD BE GIVEN TO ADDITIONS OF DIVALENT
CATIONS (CA++ AND MG++) WHICH HAVE BEEN SHOWN TO CAUSE EMULSION INSTABILITY.
AMINO ACID SOLUTIONS EXERT A BUFFERING EFFECT PROTECTING THE EMULSION.

THE ADMIXTURE SHOULD BE INSPECTED CAREFULLY FOR &LDQUO;BREAKING OR OILING
OUT &LDQUO; OF THE EMULSION. &LDQUO;BREAKING OR OILING OUT&RDQUO;
IS DESCRIBED AS THE SEPARATION OF THE EMULSION AND CAN BE VISIBLY IDENTIFIED
BY A YELLOWISH STREAKING OR THE ACCUMULATION OF YELLOWISH DROPLETS IN THE ADMIXED
EMULSION. THE ADMIXTURE SHOULD ALSO BE EXAMINED FOR PARTICULATES. THE ADMIXTURE
MUST BE DISCARDED IF ANY OF THE ABOVE IS OBSERVED.

4. Use a non-vented infusion set or close the air vent on a vented
set. Follow the instructions for use for the infusion set. Use a spike
conforming to ISO 8536-4, diameter 5.6 ± 0.1 mm.

5. The bag should be port side up when the infusion set is attached.
Insert the spike straight into the set port. Twist and push the spike
through the diaphragm.
Do not spike bag while the bag is hanging on the IV pole.

6. The step of the spike (shown by the arrow) should not be inserted
into the port.